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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSS0500113 风疹病毒IgM抗体诊断试剂盒(酶联免疫捕获法) Diagnostic reagent IVD New Drug Application 2005-10-21 珠海经济特区海泰生物制药有限公司 Zhuhai SEZ Haitai Biological Pharmaceuticals Co Ltd In Approval 2008-12-04 view
CXSS0500112 麻疹病毒IgM抗体诊断试剂盒(酶联免疫捕获法) Diagnostic reagent IVD New Drug Application 2005-10-21 珠海经济特区海泰生物制药有限公司 Zhuhai SEZ Haitai Biological Pharmaceuticals Co Ltd In Approval 2008-12-04 view
CXSS0500111 弓形虫IgM抗体诊断试剂盒(酶联免疫捕获法) Diagnostic reagent IVD New Drug Application 2005-10-21 珠海经济特区海泰生物制药有限公司 Zhuhai SEZ Haitai Biological Pharmaceuticals Co Ltd Approval Completed-Pending Certificated view
CXSS0500110 狂犬病毒IgG抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD New Drug Application 2005-10-21 珠海经济特区海泰生物制药有限公司 Zhuhai SEZ Haitai Biological Pharmaceuticals Co Ltd Certificate Issued 2008-06-27 view
CXSS0500114 破伤风IgG抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD New Drug Application 2005-10-21 珠海经济特区海泰生物制药有限公司 Zhuhai SEZ Haitai Biological Pharmaceuticals Co Ltd Certificate Issued 2008-06-27 view
X0400448 SARS 冠状病毒抗原诊断试剂盒(酶联免疫法) Diagnostic reagent IVD New Drug Application 2004-02-04 珠海经济特区海泰生物制药有限公司 Zhuhai SEZ Haitai Biological Pharmaceuticals Co Ltd Certificate Completed-Pending Issued 2004-06-07 view
CSS20020055 弓形虫IgG抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD(2) New Drug Application 2002-09-10 珠海经济特区海泰生物制药有限公司 Zhuhai SEZ Haitai Biological Pharmaceuticals Co Ltd Certificate Issued 2004-04-02 view